INTRODUCTION
Molluscum contagiosum (MC) is a highly contagious viral skin disease characterized by raised, umbilicated, pink-to-red lesions.1 It is estimated that 6 million Americans suffer from MC, mostly children.2 US Food and Drug Administration(FDA)–approved prescription medication treatments for MC remain elusive,3 and an estimated two-thirds of patients with molluscum go untreated.4 MC infections may, therefore, persist from months to years.1
Nitric oxide (NO) is a small gaseous molecule with multiple physiologic and molecular functions, possessing immunomodulatory and antimicrobial properties.5 In the body, NO has a very short half-life and is metabolized to nitrate.5 The short half-life of NO and known endogenous functions make it a desirable therapeutic candidate for various diseases. However, NO is an unstable gas, and efforts to harness and control its release as a potential topical treatment for dermatologic diseases has been challenging.6
The active ingredient in berdazimer gel, 10.3% is berdazimer sodium, a new chemical entity affixed to a diazeniumdiolate silicon backbone that holds stable NO molecules.7 When combined with a hydrogel (proton donor) on the skin, NO is released in a controlled manner at the site of application.6 In vitro, berdazimer acts as an anti-viral and may have immunomodulatory properties, thus having the potential to influence multiple cellular and molecular aspects of MC pathogenesis.6,7 The objective of this open-label, multicenter trial was to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of berdazimer (SB206) gel, 10.3% once daily for the topical treatment of MC under maximal use conditions.
Nitric oxide (NO) is a small gaseous molecule with multiple physiologic and molecular functions, possessing immunomodulatory and antimicrobial properties.5 In the body, NO has a very short half-life and is metabolized to nitrate.5 The short half-life of NO and known endogenous functions make it a desirable therapeutic candidate for various diseases. However, NO is an unstable gas, and efforts to harness and control its release as a potential topical treatment for dermatologic diseases has been challenging.6
The active ingredient in berdazimer gel, 10.3% is berdazimer sodium, a new chemical entity affixed to a diazeniumdiolate silicon backbone that holds stable NO molecules.7 When combined with a hydrogel (proton donor) on the skin, NO is released in a controlled manner at the site of application.6 In vitro, berdazimer acts as an anti-viral and may have immunomodulatory properties, thus having the potential to influence multiple cellular and molecular aspects of MC pathogenesis.6,7 The objective of this open-label, multicenter trial was to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of berdazimer (SB206) gel, 10.3% once daily for the topical treatment of MC under maximal use conditions.
MATERIALS AND METHODS
Study Design
This was a phase 1, 12-week, open-label, multicenter trial designed to evaluate the safety, tolerability, and PK parameters of berdazimer gel, 10.3% applied topically once daily for the
This was a phase 1, 12-week, open-label, multicenter trial designed to evaluate the safety, tolerability, and PK parameters of berdazimer gel, 10.3% applied topically once daily for the
